Primary and Secondary Endpoints Met for Novel Diabetes Drug

Merck and Pfizer recently announced positive results from a pair of phase 3 studies for the experimental type 2 diabetes drug ertugliflozin.

In the 2 studies, VERTIS Mono and VERTIS factorial, researchers found that the SGLT-2 inhibitor met its primary endpoints showing reductions of A1C, according to a press release from Pfizer.

VERTIS Mono included 461 patients with type 2 diabetes to analyze ertugliflozin monotherapy. Researchers found that patients taking the drug had A1C reductions of .99% (5-mg dose) and 1.16% (15-mg dose) compared with placebo.

According to the study, 28.2% of patients taking 5-mg of ertugliflozin and 35.8% of patients taking 15-mg had A1C of less than 7%. Only 13.1% of patients in the placebo group achieved this secondary endpoint.

VERTIS Factorial analyzed the combination of ertugliflozin and sitagliptin (Januvia) among 1233 patients with type 2 diabetes. Researchers found that a combination of the 2 drugs resulted in larger decreases in A1C compared with monotherapy of either drug, meeting its primary endpoint.

Patients taking ertugliflozin 5-mg or 15-mg with sitagliptin 100-mg had a reduction of 1.5%. Patients taking either dose of ertugliflozin or sitagliptin monotherapy had a reduction of 1.1%, according to the study.

Researchers also found that the combination of the drugs had an increased effectiveness than either drug alone at achieving the secondary endpoint of an A1C of less than 7%. This goal was met by 52.3% of patients taking ertugliflozin 5-mg and sitagliptin 100-mg, and 49.2% of patients taking ertugliflozin 15-mg and sitagliptin 100-mg, according to Pfizer.

Merck and Pfizer are planning to submit New Drug Applications for ertugliflozin and combination tablets of ertugliflozin plus Januvia and ertugliflozin plus metformin.

“Merck’s goal in our diabetes development program is to evaluate new treatment options to advance the care of people with type 2 diabetes around the world,” concluded Peter Stein, MD, vice president of late stage development, diabetes and endocrinology at Merck. “We are encouraged that these first Phase 3 studies of investigational ertugliflozin met their primary endpoints for ertugliflozin as a monotherapy and in combination with sitagliptin, and we look forward to progressing the VERTIS clinical development program with Pfizer.”